Method and apparatus for treating pelvic pain

ABSTRACT

A hand-held internal therapeutic massager includes a rod having a first portion that defines a curve and a second portion that is substantially straight. The first portion of the rod is adapted to be inserted into a patient&#39;s body. A curvature of the curve defined by the first portion of the rod is sufficient to prevent the second portion of the rod from entering a patient&#39;s body. A handle is located on the second portion of the rod and a pressure applicator on the first portion of the rod is adapted to be inserted into the patient&#39;s body for engagement with a localized area of myofascial tissue. A vibratory device is disposed within the handle and is operable to generate vibrations. The vibrations generated by the vibratory device are conducted through the rod to the pressure applicator to the localized area of myofascial tissue.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of U.S. patent applicationSer. No. 13/723,263, filed Dec. 21, 2012, which is a continuation ofU.S. patent application Ser. No. 12/115,807, filed May 6, 2008, whichclaims the benefit of U.S. Provisional Patent Application No.60/928,033, filed May 7, 2007.

FIELD OF THE INVENTION

The present invention relates to a method and apparatus for treatingpelvic pain in women and men.

BACKGROUND OF THE INVENTION

Pelvic pain has long been a problem among women and men. Conventionalmedicine has treated pelvic pain in various ways including, 1) anorgan-specific focus in which pelvic pain is believed to be a symptom ofinflammation in the bladder, inflammation or infection in the prostategland, or pathology of the uterus; 2) focus on the idea of the pudendalnerve being entrapped and needing release; 3) focus on an autoimmuneprocess; or 4) focus supposed on psychiatric problems deriving from afear of sexual activity, a propensity toward malingering, or neuroticsomatization. While all of these treatments have failed to resolve theproblem of pelvic pain, an example of one of these approaches is shownin U.S. Pat. No. 2,478,786, which shows a prostate gland massagingimplement. In the field of urology, prostate massage derives from thegoal of expelling the prostate fluid suspected of containinginflammatory or infectious pathogens, for treating urinary frequency,urgency, dysuria and other related symptoms of bacterial or inflammatoryprostatitis.

The approaches described above are based on a misunderstanding of thenature of most cases of pelvic pain commonly diagnosed as prostatitis.In recent years, evidence has emerged that a large majority of pelvicpain in men and women is related to muscle dysfunction and musclerelated pain. Understanding most cases of prostatitis and pelvic pain asmuscle related pain is an entirely new paradigm in urology. This newunderstanding sees chronic tension in the pelvic muscles producingtrigger points, or taut bands within muscles either at the surface ofthe muscle, inside the muscle, in the belly or the attachment of themuscle. These trigger points are rather like mini-spasms in muscle thatrefer pain to remote sites, and when pressed routinely recreate apatient's symptoms. When pressed in a specific way these trigger pointscan release, often attended by a significant reduction or abatement inpain and dysfunction. Trigger points have been found to be stronglyexacerbated with anxiety and other perpetuating factors. Trigger pointrelease, particularly for trigger points located on the outside of thebody has become a subspecialty within medicine. The inventor of thepresent invention, David Wise, Ph.D, along with his colleague andcoauthor Rodney Anderson, M.D., professor of urology at StanfordUniversity, previously described techniques for identifying andmanipulating trigger points in their book A Headache in the Pelvis: ANew Understanding and Treatment for Prostatitis and Chronic Pelvic PainSyndromes, which was originally published by the National Center forPelvic Pain Research in 2003, and is incorporated herein in its entiretyby reference.

The research of Wise, Anderson and Sawyer has discovered that dailytrigger point release along with other methods provides the mosteffective relief for pelvic pain. Many pelvic pain patients do not haveaccess to professionals competent in internal trigger point release, arenot able to afford the ongoing level of treatment, or are not able tofind the time necessary to receive trigger point release. Thus, manypatients have an urgent need for ongoing trigger point release relatedto pelvic pain that remains unmet due to the financial and time relatedproblems existing in conventional professional treatment of internaltrigger points and to the scarcity of internal trigger pointpractitioners. Previously known self-treatment apparatuses have provenineffective for internal trigger point release because they weredesigned for other purposes and not for internal trigger point release.Previous apparatuses have not had the structural design to enable thepatient to locate the often hard to find internal trigger points, norhave they provided any assistance in applying the appropriate pressureto release the trigger point and, importantly, at the same time to causeno bleeding tissue damage or perforation.

Accordingly, need remains for a method and apparatus by which patientscould treat their own internal trigger points, accessed either vaginallyor rectally using trigger point release techniques, without need for avisit to a physician or therapist.

SUMMARY OF THE INVENTION

In accordance with the invention, an apparatus and method for treatingpelvic pain is provided. The apparatus includes a rod or wand having ahandle attached to a straight portion at a first end of the wand and apressure applicator attached to a second end of the wand, where a firstcurved portion is disposed between the straight portion of the wand andthe second end of the wand. The first curved portion may besubstantially semicircular, and may define an arc of approximately 180degrees.

In some embodiments, the apparatus includes a wand having a secondcurved portion disposed between the first curved portion and the secondend of the wand. The second curved portion of the wand may form an anglebetween 45 to 90 degrees with respect to the first curved portion of thewand, and the first curved portion of the wand and the second curvedportion of the wand may cooperate to define a reverse curve.

In other embodiments, the apparatus includes a stop or platform that isadjustably disposed on the wand for adjustably restraining insertion ofthe pressure applicator into the body cavity. The stop includes a flangethat is engageable with an external surface of the patient's body and acollar that is disposed on the wand. A positioning element may beprovided on the collar of the stop, the positioning element moveablebetween an engaged position, where the positioning element engages thewand to restrain movement of the stop with respect to the wand, and adisengaged position, where the positioning element does not engage thewand and does not restrain movement of the stop with respect to thewand. Furthermore, the positioning element may have a threaded apertureformed through the collar and a set screw receivable within the threadedaperture for engagement with the wand.

In some other embodiments, the apparatus may include a pressure sensorand a display electrically connected to the pressure sensor to display apressure value. The pressure sensor may be disposed in the pressureapplicator, or the pressure sensor may be disposed in the straightportion of the wand.

In yet another embodiment, the pressure applicator is fabricated from anelectrically conductive material, the wand fabricated from anon-electrically conductive material, and the apparatus includes anelectrical stimulation unit electrically connected to the pressureapplicator for supplying electrical current to the pressure applicator.

In the method of the present invention, a trigger point is located inthe patient's pelvic floor. With a lubricated glove or condom coveringthe distal end, the patient inserts the apparatus either vaginally orrectally to allow contact of the pressure applicator of the apparatuswith one or more trigger points located on the pelvic floor, andpressure is applied to the trigger point using the apparatus in order torelease the trigger point.

In one embodiment, a hand-held internal therapeutic massager includes arod having a first portion that defines a curve and a second portionthat is substantially straight. The first portion of the rod is adaptedto be inserted into a patient's body. A curvature of the curve definedby the first portion of the rod is sufficient to prevent the secondportion of the rod from entering a patient's body. A handle is locatedon the second portion of the rod and a pressure applicator on the firstportion of the rod is adapted to be inserted into the patient's body forengagement with a localized area of myofascial tissue. A vibratorydevice is disposed within the handle and is operable to generatevibrations. The vibrations generated by the vibratory device areconducted through the rod to the pressure applicator to the localizedarea of myofascial tissue.

BRIEF DESCRIPTION OF THE DRAWINGS

The description herein makes reference to the accompanying drawings,wherein like reference numerals refer to like parts throughout theseveral views, and wherein:

FIG. 1 is an illustration showing a first embodiment of the apparatusfor treating pelvic pain according to the invention;

FIG. 2 is an illustration showing use of the first embodiment of theapparatus for treating pelvic pain according to the invention by a user;

FIG. 3 is a partial cross section of the pelvis of the user showingengagement of the first embodiment of the apparatus for treating pelvicpain according to the invention with a myofascial trigger point;

FIG. 4 is a side view of a second embodiment of the apparatus fortreating pelvic pain according to the invention;

FIG. 5 is a side view of a third embodiment of the apparatus fortreating pelvic pain according to the invention;

FIG. 6 is a side view of a fourth embodiment of the apparatus fortreating pelvic pain according to the invention;

FIG. 7 is a side view of a fifth embodiment of the apparatus fortreating pelvic pain according to the invention;

FIG. 8 is a side view of a sixth embodiment of the apparatus fortreating pelvic pain according to the invention; and

FIG. 9 is a side view of a seventh embodiment of the apparatus fortreating pelvic pain according to the invention.

FIG. 10 is a side view of an eighth embodiment of the apparatus fortreating pelvic pain according to the invention.

FIG. 11 is a side view of a ninth embodiment of the apparatus fortreating pelvic pain according to the invention.

FIG. 12 is a side view of a tenth embodiment of the apparatus fortreating pelvic pain according to the invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Referring to FIGS. 1-3, there is shown an apparatus 10 in accordancewith a first embodiment of the invention. The apparatus 10 includes asubstantially j-shaped rod or wand 12, a handle member 14 connected to afirst end of the wand 12, and a pressure applicator 16 connected to asecond end of the wand 12. The handle member 14 and the pressureapplicator 16 are connected to the wand 12 in any suitable conventionalmanner. The wand 12, the handle member 14, and the pressure applicator16 may be fabricated from any suitable material, such as acrylic.

The wand 12 is a continuous member that has a straight portion 18 thatextends from the handle member 14 for approximately ten inches beforereaching a semicircular portion 20. The semicircular portion 20 definesan arc of approximately 180 degrees. However, it should be understoodthat the semicircular portion 20 need not be exactly semicircular, aslong as it forms a generally u-shaped curve. The wand 12 may be eitherhollow or solid, as desired. The wand 12 is substantially slendermember, having a diameter of, for example, three-eighths to one-half ofan inch, such that the diameter of the wand 12 is large enough toprovide sufficient strength to the apparatus 10 to allow the user toapply pressure using the pressure applicator 16 without unduedeformation of the apparatus 10. Furthermore, this dimension isconsidered critical in that the diameter of the wand 12 must be smallenough so that rectal insertion of the apparatus 10 does not inducedefecation when the wand 12 is inserted rectally by a patient and sothat the uncomfortable sensation caused by insertion of the wand 12 doesnot overpower the patient's ability to sense engagement of the pressureapplicator 16 of the apparatus 10 with a trigger point 3.

The pressure applicator 16 is a substantially spherical orsemi-spherical member adapted for engagement with trigger points 3 inthe pelvic floor 4, as will be explained herein. The pressure applicator16 is sized similarly to the tip of a human index finger (not shown) andis between nine-sixteenths of an inch in diameter and one andone-quarter inches in diameter. Preferably, the pressure applicator 16is approximately eleven-sixteenths of an inch in diameter, which allowseffective, safe pressure to be applied to the trigger point 3 to causepalpation of the trigger point. This range of dimensions is consideredcritical in that pressure applicators 16 in larger sizes, such as oneinch and seven-eighths of an inch in diameter were tested and found tobe unsuitable, as these pressure applicators 16 did not allow sufficientpressure to be applied to trigger points and made locating triggerpoints 3 difficult. Conversely, pressure applicators 16 in smaller sizesmake palpating the trigger points 3 difficult and can cause excessivepressure to be applied. Although shown and described herein assubstantially spherical, it should be understood that the pressureapplicator 16 could be provided in other non-spherical shapes.

The apparatus 10 is a device used for patient's self-treatment of pelvicpain to deactivate trigger points inside their own pelvic floor 4 byinserting the device vaginally or rectally. More particularly, theapparatus 10 of the first embodiment allows the user to access anteriortrigger points (trigger points toward the front of the pelvic floor 4,closer to the belly than the back) and perform ischemic compression(pressure that squeezes the blood out of what is being pressed) onanterior trigger points. It is meant to enable the user to do pressurerelease, strumming, stroking and other methods of trigger point releaseon these internal pelvic trigger points and areas of restriction,usually associated with pelvic floor 4 pain, urinary and defecatorydysfunction, on the muscles of the levator ani, coccygeus,pubococcygeus, obturator internus, piriformis and other internallyaccessed trigger points. The apparatus 10 may also be used to stretchrestricted, shortened, chronically contracted internal pelvic muscletissue so that it elongates and reduces in its pain, soreness andability to refer these sensations. Trigger point release using theapparatus 10 involves finding the internal trigger point 3, which isdescribed in detail in the 4th edition of A Headache in the Pelvis andin Travell and Simon's book, A Trigger Point Therapy Manual, holding itand pressing on it for a period of 30-90 seconds to release it andreduce it's ability to refer pain and symptoms to sites either remotefrom it or directly at the site of palpation.

The trigger point release aims to free the muscles in and around thepelvis of active trigger points 3 and to restore the muscles of thepelvic floor 4 to a flexible and lengthened state. The phenomenon oftrigger points was introduced into medicine by Travell and Simon whopublished the first edition of Myofascial Pain and Dysfunction: TheTrigger Point Manual in 1983, which was followed by a second edition in1992. These books were the culmination of research that went back to1942 when Dr. Travell published her first article on myofascial pain.

The concept of trigger points 3 is relatively new to medicine. Triggerpoints 3 are specifically defined herein as taut bands within a muscle,either at the surface of the muscle or inside the muscle, in the bellyor at the attachment of the muscle. The trigger point 3characteristically elicits a twitch response, detectable on ultrasoundor via electromyograph (a machine that measures the electrical activityin a muscle in millionths of a volt), that can be felt by a trainedpractitioner while palpating the trigger point. When the trigger pointis pressed, there is often a ‘jump’ response in the patient due to thereflexive reaction of the patient to the often exquisite tenderness ofthe trigger point upon palpation. Furthermore, the trigger point 3characteristically refers pain/sensation to the site being pressed or toa site remote from it.

A trigger point 3 can be active or latent. An active trigger point 3 isconsidered able to refer pain and recreate that pain upon palpation whenthe patient comes in with a complaint of pain. A latent trigger point 3has the capacity to be the source of pain (i.e., has the capacity tobecome an active one) and under certain circumstances, becomes activebut generally the patient does not complain of symptoms from latenttrigger points. Trigger points 3 are latent in many people. Triggerpoints 3 refer pain directly on the trigger point 3 site or to a remotesite, which means that where pain is felt is often not where it actuallyis coming from. For instance, testicular pain is often referred fromtrigger points in the quadratus lumborum. This is not obvious and isanti-intuitive. This trigger point 3 can be around 8-10 inches away fromthe site of the discomfort. The internal muscles that contain triggerpoints 3 are often close to each other. The relationship betweensymptoms and the location of associated trigger points 3 is mostly foundin Travell and Simon's textbooks.

Before using the apparatus 10, the patient receives instruction on theuse of the apparatus 10 by a qualified physician, osteopath, nurse,physical therapist or other designated professional. After receivingcompetent instruction, the user may use the apparatus 10 while sittingdown on a toilet seat, in the lithotomy position lying down with thelegs parted, a position commonly used in the gynecologist office when adoctor does a digital vaginal examination, or while the user lies on hisor her side. The apparatus 10 is held in front of the patient's body,with the straight portion 18 of the wand 12 extending along the torso ofthe user's body, toward the user's head, and the pressure applicator isinserted, for example, through the rectal opening 5 and into the rectalcavity 6. One of the user's hands 2 a holds the handle 14 and pushesaway from the user's body, while the other hand 2 b holds the straightportion 18 of the wand 12 of the apparatus 10 near the semicircularportion 20 of the wand 12 and pulls it toward the body, thereby exertingpressure on the pressure applicator 16 of the apparatus 10 at a level ofpressure of 1-12 lbs. as measured by the flexion of the straight rod atits tip as it engages the pelvic floor 4, in order to access and palpateanterior trigger points 3. A condom or rubber gloves are always placedover the tip of the apparatus 10 coming up 8-12 inches and sterilelubrication like KY Jelly® or Surgilube® is used to facilitate easyinsertion and removal of the apparatus 10.

All of the internal trigger points 3 must be thoroughly evaluated andtreated. When trigger points 3 are located, they are held with pressurerelease using the apparatus 10 which involves pressing on a triggerpoint 3 with constant pressure, usually for a period of 30-90 seconds.So that the patient may readily measure the elapsed time during triggerpoint release, the apparatus may include a timer (not shown) on the wand12 or the handle member 14 of the apparatus 10.

Specific trigger points 3 in specific pelvic muscles tend to referspecific kinds of symptoms. For example, pain in the tip of the penis orthe sense of urgency and frequency is typically created by activetrigger points 3 in the anterior (front) portion of the levator animuscle. When a patient uses the apparatus 10, knowledge of therelationship between symptoms and pelvic trigger points 3 is essentialto be able to use the wand properly and instructions in the use of theapparatus 10 are part of its proper use and appropriate prescription bya physician or designated health care professional.

As shown in FIG. 4, an apparatus 110 according to a second embodiment ofthe invention includes all of the elements of the apparatus 10 of thefirst embodiment as well as an adjustable platform or stop 130 that isdisposed on the wand 12. The adjustable stop 130 serves to limit thedepth to which the user of the apparatus 110 may insert the pressureapplicator 16 into the vagina or rectum.

This adjustable stop 130 allows the user to determine how far in toinsert the wand 12 in order to accurately find and release internalpelvic floor 4 trigger points 3. At first, the position of theadjustable stop 130 on the wand 12 is adjusted by a therapist who hasmapped out the user's internal trigger points 3 and who is teaching theuser how to locate, self-treat and release her or his own trigger points3. This is necessary since the locations of internal trigger points 3are very difficult to discern, since patients are often incapable ofaccurately sensing the location of the pressure applicator 16 of thewand 12 once inserted. Thus, the user's doctor or therapist maydetermine the appropriate depth or depths at which the wand 12 needs tobe inserted to access the trigger points 3 on which release will beperformed by the patient. With the insertion depth fixed, the user maythen identify the trigger point 3 location or locations more easily,since the range of motion of the pressure applicator 16 of the wand 12is limited by engagement of the adjustable stop 130 with the exterior ofthe patient's body. Also, by using the adjustable stop 130, the maximumdepth of insertion of the wand 12 is limited, thereby reducing the riskof patient injury, such as tissue bleeding, damage or internal organperforation.

The adjustable stop 130 includes a flange 132 that extends radiallyoutward from a collar 134 that is slidably disposed upon the wand 12.The flange 132 lies substantially perpendicular to the longitudinal axisof the wand 12, and is adapted to engage the exterior of the user's bodyto restrain the apparatus 110 against further insertion. The collar 134is substantially tubular, and has an internal diameter complementary tothe external diameter of the wand 12. A positioning element 136, such asa set screw, extends through a threaded aperture 138. The positioningelement 136 moves between an engaged position, where the positioningelement 136 engages the wand 12 to restrain movement of the adjustablestop 230 with respect to the wand 12, and a disengaged position, wherethe positioning element 136 does not engage the wand 12 and theadjustable stop 130 is not restrained from moving with respect to thewand 12. Thus, when the positioning element 136 of the adjustable stop130 is in the disengaged position, the adjustable stop 130 may be slidalong the wand 12 to any desired location on the straight portion 18 orthe semicircular portion 20 of the wand 12. Then, when the adjustablestop 130 is in a desired position, the positioning element 136 may bemoved to the engaged position to lock the adjustable stop 130 in thedesired position.

As shown in FIG. 5, an apparatus 210 according to a third embodiment ofthe invention includes a wand 212 having a primary curved portion 220that is similar to the semicircular portion 20 of the apparatus 10 ofthe first embodiment, as well as a secondary curved portion 222 that isdisposed between the primary curved portion 220 of the wand 212 and apressure applicator 216 that is similar to the pressure applicator 16 ofthe apparatus 10 of the first embodiment. The primary curved portion 220forms a generally u-shaped curve and may be substantially semicircular.The apparatus 210 also includes a handle 214 that is connected to astraight portion 218 of the wand 212. The handle 214 and the straightportion 218 are similar to the handle 14 and straight portion 18 of theapparatus 10 of the first embodiment.

The secondary curved portion 222 of the wand 212 is positioned along thewand so that it is disposed internally when the pressure applicator 216is engaged with a trigger point 3. The secondary curved portion forms anangle between 45 to 90 degrees with respect to the primary curvedportion 220, and the primary curved portion 220 and the secondary curvedportion 222 may cooperate to define a reverse curve.

By providing the secondary curved portion 222 on the wand 212, the usermay engage the pressure applicator 216 with posterior trigger points 3(trigger points 3 located toward the back of the body, closer to theback than the belly), such as trigger points 3 on the coccygeus muscles,to perform ischemic compression, milking, or strumming of those triggerpoints 3.

As shown in FIG. 6, an apparatus 310 according to a fourth embodiment ofthe invention includes a pressure sensor (algometer) 322 that isdisposed within a pressure applicator 316. The wand 312, the handle 314,and the pressure applicator 316 are similar to the wand 12, the handle14, and the pressure applicator 16 of the apparatus 10 of the firstembodiment, respectively.

The pressure sensor 322 may be any conventional sensor operable tooutput an electrical signal corresponding to a sensed pressure value,and thus, the pressure sensor 322 is operable to detect the pressureapplied to the trigger point 3 by the pressure applicator 316 of thewand. To provide information regarding the pressure applied by thepressure applicator 316 to the user, the pressure sensor 322 iselectrically connected to a display 324 by a cable 326. The display 324is a conventional digital or analog device operable to display ameasured value corresponding to the measurement made by the pressuresensor 322 and thus allows the pressure applied by the pressureapplicator 316 to be monitored by the patient during use of theapparatus 310. The display 324 may be disposed external to the wand 312and the handle 314 in a separate housing, and the cable 326 may extendthrough the wand 312 and out of the handle 314 to the display 324.Alternatively, the display 324 may be disposed on the straight portion318 of the wand 312 or on the handle 314. Provision of the pressuresensor 322 and the display 324 allows the patient to apply the amount ofpressure to the trigger point 3 prescribed by the patient's doctor ortherapist, thereby facilitating effective, safe trigger point 3 release.

As shown in FIG. 7, an apparatus 410 according to a fifth embodiment ofthe invention includes a flexible pressure sensor 422 that is disposedwithin a straight portion 418 of a wand 412, adjacent to a handle 414.The flexible pressure sensor 422 is, for example, a flexible bend sensorthat produces a changing output signal, such as resistance, as thedegree of bending of the sensor occurs. Thus, the flexible pressuresensor 422 is an elongated body that is disposed within or embeddedwithin the handle 414. The flexible pressure sensor 422 is electricallyconnected to a display 424 by a cable 426, which are similar to thedisplay 324 and cable 326 of the apparatus 310 of the fourth embodiment,respectively. During use of the apparatus 410, the user places a firsthand 2 a on the handle 414 of the apparatus 410, and a second hand 2 bon the straight portion 418 of the wand 412. Thus, when pressure isapplied to the trigger point 3 using the pressure applicator 16 (notshown in FIG. 7), a deflection is induced in the straight portion 418 ofthe wand 412. This deflection is measured by the flexible pressuresensor 422 and, since it corresponds to the pressure applied by thepressure applicator 16, is converted to a pressure reading and output onthe display 424.

As shown in FIG. 8, an apparatus 510 according to a sixth embodiment ofthe invention includes an electrical stimulation unit 524. The wand 512,the handle 514, and the pressure applicator 516 are similar to the wand12, the handle 14, and the pressure applicator 16 of the apparatus 10 ofthe first embodiment, respectively. However, the wand 512 of theapparatus 510 is fabricated from a non-electrically conductive material,such as acrylic, while the pressure applicator 516 is fabricated from anelectrically conductive material. The electrical stimulation unit 524 isdisposed external to the wand 512 and the handle 514, and iselectrically connected to the pressure applicator 516 by a cable 522that extends through the wand 512 and out of the handle 514. Theelectrical stimulation unit 524 is a conventional unit that is adaptedto provide electrical current for electrical stimulation of muscles.Thus, the pressure applicator 516 may apply both pressure and electricalstimulation to the trigger point 3 using the electrical stimulation unit524.

As shown in FIG. 9, an apparatus 610 according to a seventh embodimentof the invention includes a removable pressure applicator 616. The wand612, the handle 614, and the pressure applicator 616 are similar to thewand 12, the handle 14, and the pressure applicator 16 of the apparatus10 of the first embodiment, respectively. However, a threaded portion622 is provided at the distal end of the curved portion 620 of the wand612, and a threaded recess 624 is provided on the pressure applicator616. Thus the pressure applicator 616 may be threadedly connected anddisconnected from the wand 612. By providing a selectively detachablepressure applicator 616, a plurality of pressure applicators 616 may beprovided having various diameters ranging between nine-sixteenth of oneinch in diameter and one and one-quarter inches in diameter. Thus, thepatient may utilize the apparatus with a larger diameter pressureapplicator 616 when the trigger point 3 is near the surface, and mayutilize a smaller diameter pressure applicator 616 when the triggerpoint 3 is located deep within the patient's muscles.

As shown in FIG. 10, an apparatus 710 according to an eighth embodimentof the invention includes a vibratory device 730. The wand 712, thehandle 714, and the pressure applicator 716 are similar to the wand 12,the handle 14, and the pressure applicator 16 of the apparatus 10 of thefirst embodiment, respectively. However, the vibratory device 730 isdisposed within a recess that is formed in the handle 714, which islocated at one end of the wand 712 opposite the pressure applicator 716,with the handle 714 extending generally transverse to the wand 712. Thevibratory device 730 is operable to generate vibrations. The vibrationsgenerated by the vibratory device 730 can be of various frequencies andintensities.

In the illustrated example, the vibratory device 730 includes one ormore control switches 732 to control the frequency (speed) and/orintensity of vibration generated by the vibratory device 730. Forexample, an intensity of the vibrations generated by the vibratorydevice 730 can be infinitely adjustable or discretely adjustable betweena minimum intensity value and a maximum intensity value using the one ormore control switches 732. Furthermore, for example, a frequency (speed)of the vibrations generated by the vibratory device 730 can beinfinitely adjustable or discretely adjustable between a minimumfrequency value and a maximum frequency value using the one or morecontrol switches. In one implementation, the vibratory device has afrequency that is adjustable from 0 to 180 cycles per second. As will beexplained, adjustment of the vibratory device 730 changes the motioninduced at the pressure applicator 16, ranging from subtle vibration toa wobbling motion that mimics the manual strumming technique triggerpoint release therapy.

In one implementation, the vibratory device includes an electromagneticmotor that produces vibration as a function of rotation, for example,using an eccentric weight. In another implementation, vibration isproduced using a piezoelectric transducer or an ultrasonic device, suchas an ultrasonic motor, which produce vibration in response to anelectrical signal (waveform) that controls the intensity and thefrequency of the vibration that is generated, where the electricalsignal is generated by a control circuit of the vibratory device 730.The vibratory device 730 can be internally-powered, such as bybatteries, or can be externally powered, by connection, such as a wiredelectrical connection, to an external power source.

In operation, the vibratory device 730 produces vibrations that areconducted along the wand 712, which can be a solid rod formed of aresilient material, and through the pressure applicator 716 to delivergentle vibration to a treatment site, such as a myofascial trigger pointof on the patient's pelvic floor, which is access via a rectal cavity ora vaginal cavity of the patient, as previously described. By locatingthe vibratory device 730 outside of the patient's rectal cavity orvaginal cavity, electrical components are not placed within the patient.Furthermore, the remote location of the vibratory device 730 attenuatesthe vibration to prevent overstimulation of the treatment site. Inaddition, as a result of the location of the vibratory device beingwithin or adjacent to the handle, in combination with the curved shapeof the wand 712, the vibration generated by the vibratory device caninduce a wobbling motion at the pressure applicator 716, especially whenlow frequency, large amplitude vibrations are generated by the vibratorydevice 730. This wobble mechanically mimics the method of manualstrumming in trigger point release, by which the pressure applicator 716is moved across the fibers of a muscle, and by adjusting the vibrationproduced by the vibratory device 730, a finer or rougher wobble can beinduced at the pressure applicator 716.

As shown in FIG. 11, an apparatus 810 according to an ninth embodimentof the invention includes a vibratory device 830 and one or more controlswitches 832. The wand 812, the handle 814, and the pressure applicator816 are similar to the wand 12, the handle 14, and the pressureapplicator 16 of the apparatus 10 of the first embodiment, respectively.The vibratory device 830 and the one or more control switches 832 aresimilar to the vibratory device 830 and the one or more control switches832. However, the vibratory device 830 is disposed within a recess thatis formed in the wand 812. The vibratory device 830 is disposed withinthe wand 812 adjacent to an end of the wand 812, adjacent to the handle814, and spaced apart from the curved portion of the wand 812 and thepressure applicator 816. The use and effects of the apparatus 810 aresimilar to those of the apparatus 710.

The apparatus 710 of FIG. 10 and the apparatus 810 of FIG. 11 can bothbe utilized in conjunction with features previously described withrespect to other embodiments. For example, the stop 130 of the apparatus110 can be incorporated with either of the apparatus 710 or theapparatus 810 such that the stop 130 is disposed between the vibratorydevice 730, 830 and the pressure applicator 716, 816, and prevents thevibratory device 730, 830 from entering the patient's vaginal cavity orrectal cavity.

FIG. 12 is a side view of a tenth embodiment of an apparatus 910 fortreating pelvic pain according to the invention. The apparatus 910includes a wand 912, which is as described in previous embodiments andcan include or be used with the various features shown in previousembodiments. A pressure applicator 920 is located at one end of the wand912. In the illustrated example, a narrowed end 914 of the wand isreceived within a bore 922 defined by the pressure applicator, and anominal outer diameter of the wand 912 is wider than the narrowed endand is substantially the same as an outside diameter of a base 924 ofthe pressure applicator 920. At least part of the end portion 926 of thepressure applicator has a substantially spherical shape, which changesto a frustroconical shape at a transition section 928 that provides agradual change in diameter for the pressure applicator 920, which canaid insertion and removal of the pressure applicator, thus improvingpatient comfort.

In one implementation, the wand 912 and the pressure applicator 920 areformed separately. The pressure applicator 920 being formed from a lowdurometer, bio-compatible thermoplastic elastomer material, with the endportion having a diameter of about 0.75 inches, the base having adiameter of about 0.5 inches, and a length of about 1.375 inches. Thewand can be formed from a material such as ultem, and have a diameter ofabout 0.375 inches along the narrowed end, and a diameter of about 0.5inches elsewhere.

Use of the apparatuses of the second through ninth embodiments isperformed in substantially the same manner as described in connectionwith the first embodiment. Of course, it should be understood that thefeatures of the above embodiments may be combined. For example, anapparatus could be provided having the adjustable stop 130 according tothe second embodiment, the primary curved portion 220 and the secondarycurved portion 222 as demonstrated in the third embodiment, as well asthe flexible pressure sensor 422 and the display 424 of the fourthembodiment.

While the invention has been described in connection with what ispresently considered to be the most practical and preferred embodiment,it is to be understood that the invention is not to be limited to thedisclosed embodiments, but to the contrary, it is intended to covervarious modifications or equivalent arrangements included within thespirit and scope of the appended claims. The scope is to be accorded thebroadest interpretation so as to encompass all such modifications andequivalent structures as is permitted under the law.

What is claimed is:
 1. A hand-held internal therapeutic massager devicefor manually providing direct pressure to a localized area of myofascialtissue, the hand-held internal therapeutic massager device comprising: arod that is a one-piece, non-hollow member that is fabricated from anon-electrically conductive material, the rod having a first portionthat defines a curve and a second portion that is substantiallystraight, wherein the first portion of the rod is adapted to be insertedinto a patient's body and a curvature of the curve defined by the firstportion of the rod is sufficient to prevent the second portion of therod from entering a patient's body; a handle located on the secondportion of the rod; a pressure applicator that is located on the firstportion of the rod and is adapted to be inserted into the patient's bodyfor engagement with the localized area of myofascial tissue; and avibratory device that is disposed within the handle and is operable togenerate vibrations, wherein the vibrations generated by the vibratorydevice are conducted through the rod to the pressure applicator to thelocalized area of myofascial tissue.
 2. The hand-held internaltherapeutic massager device of claim 1, wherein the pressure applicatoris at least semi-spherical and is sized such that it can be insertedinto the patient's body.
 3. The hand-held internal therapeutic internalmassager device of claim 1, wherein the pressure applicator issubstantially spherical and is sized such that it can be inserted intothe patient's body.
 4. The hand-held internal therapeutic internalmassager device of claim 1, wherein the pressure applicator is sizedsuch that it can be inserted into the patient's body the rod has adiameter that is smaller than the diameter of the pressure applicator.5. The hand-held internal therapeutic internal massager device of claim1, wherein the rod is sized such that it can be inserted into thepatient's body the pressure applicator has a diameter that is largerthan the diameter of the rod.
 6. The hand-held internal therapeuticmassager device of claim 1, wherein the rod has a diameter that isbetween three eighths of an inch and one half of an inch and thepressure applicator is between nine-sixteenths of an inch and one andone quarter inches in diameter.
 7. The hand-held internal therapeuticmassager device of claim 1, wherein the curve defined by the firstportion of the rod is substantially u-shaped.
 8. The hand-held internaltherapeutic massager device of claim 1, wherein the first portion of therod defines a substantially circular curve.
 9. The hand-held internaltherapeutic massager device of claim 1, wherein the first portion of therod defines a curve of one hundred and eighty degrees.
 10. The hand-heldinternal therapeutic massager device of claim 1, wherein the vibratorydevice has at least one of an adjustable intensity or an adjustablefrequency.
 11. A hand-held internal therapeutic massager device formanually providing direct pressure to a localized area of myofascialtissue, the hand-held internal therapeutic massager device comprising: arod that is fabricated from a non-electrically conductive material, therod having a first portion that defines a curve and a second portionthat is substantially straight, wherein the rod has a diameter that isbetween three eighths of an inch and one half of an inch; a handlelocated on the second portion of the rod; a pressure applicator locatedon the first portion of the rod, wherein the pressure applicator isbetween nine-sixteenths of an inch and one and one quarter inches indiameter and is adapted to be inserted into a patient's body cavity forengagement with the localized area of myofascial tissue; a stop that isslidably disposed on the rod to adjust an insertion depth of thepressure applicator with respect to the patient's body cavity, the stophaving an opening that extends through the stop and a surface thatextends outward from the opening, wherein the rod passes through theopening and the stop is engageable with an external surface of thepatient's body; and a vibratory device that is disposed within thehandle and is operable to generate vibrations, wherein the vibrationsgenerated by the vibratory device are conducted through the rod to thepressure applicator to the localized area of myofascial tissue, whereinthe stop is disposed between the vibratory device and the pressureapplicator.
 12. The hand-held internal therapeutic massager device ofclaim 11, wherein the rod is a solid, continuous member one-piece,non-hollow member that extends continuously from the handle to thepressure applicator.
 13. The hand-held internal therapeutic massagerdevice of claim 11, wherein the second portion of the rod isapproximately ten inches long.
 14. The hand-held internal therapeuticmassager device of claim 11, wherein the first portion of the roddefines at least one of a u-shaped curve, a substantially circularcurve, or a curve of one hundred and eighty degrees.
 15. The hand-heldinternal therapeutic massager device of claim 11, wherein the pressureapplicator is substantially spherical.
 16. The hand-held internaltherapeutic massager device of claim 11, wherein the pressure applicatoris at least semi-spherical.
 17. The hand-held internal therapeuticmassager device of claim 11, wherein the stop includes a positioningelement that is moveable between an engaged position, where thepositioning element engages the rod to restrain movement of the stopwith respect to the rod, and a disengaged position, where thepositioning element does not engage the rod and does not restrainmovement of the stop with respect to the rod.
 18. The hand-held internaltherapeutic massager device of claim 17, wherein the positioning elementis a threaded element that is received in a threaded aperture of thestop.
 19. A hand-held internal therapeutic massager device for manuallyproviding direct pressure to a localized area of myofascial tissue, thehand-held internal therapeutic massager device comprising: a rod that isa one-piece, non-hollow member that is fabricated from anon-electrically conductive material, the rod having a first portionthat defines a curve and a second portion that is substantiallystraight, wherein the first portion of the rod is adapted to be insertedinto a patient's body and a curvature of the curve defined by the firstportion of the rod is sufficient to prevent the second portion of therod from entering a patient's body; a handle located on the secondportion of the rod; a pressure applicator that is located on the firstportion of the rod and is adapted to be inserted into the patient's bodyfor engagement with the localized area of myofascial tissue; and avibratory device that is disposed within the second portion of the rodand is operable to generate vibrations, wherein the vibrations generatedby the vibratory device are conducted through the rod to the pressureapplicator to the localized area of myofascial tissue.
 20. The hand-heldinternal therapeutic massager device of claim 19, wherein the vibratorydevice is located adjacent to the handle.